Implants for breast augmentation and/or reconstruction are well known and have been in use for over 20 years. During that period, the implants have undergone a number of significant changes. For example, early implants had a smooth outer shell; however, as developments progressed the smooth shell was replaced with a textured surface. This was done in an effort to reduce problems associated with capsular contraction and to support a natural or pear shaped implant in position.
One approach to the use of a textured surface is disclosed in my co-pending U.S. patent application Ser. No. 12/169,000 filed on Jul. 8, 2008, that is a Continuation-In-Part of U.S. patent application Ser. No. 12/026,032 filed on Feb. 5, 2008. As disclosed therein, a method for texturing the surface of a synthetic implant includes the steps of providing an implant having a textured outer layer of silicone elastomer having a plurality of cavities filled with tissue growth enhancing material. Portions of the tissue growth enhancing materials protrude outwardly from the filled cavities. The implant also includes a hollow core filled with a fluid gel or liquid of silicone, saline or soy and a layer or mass of a biologically active non-absorbable material such as non-absorbable acellular dermis. The method also includes the step of forming a capsular pouch from the mass of biologically active non-absorbable material, placing the implant into the pouch and implanting the pouch containing the implant behind the breast thus holding the implant in position and reducing capsular contraction by the surrounding tissue and blood and blood vessels growing into the acellular dermis. In a preferred embodiment of the invention the acellular dermis, collagen are combined with hyaluronic acid and partially impregnated in the outer layer of silicone elastomer so that the patient's blood vessels and tissue grow into the biologically active non-absorbable or only partially absorbable filled cavities to thereby anchor the implant in place.
It is well known that a human body forms a capsule around a synthetic implant. It is also well known that when a soft implant such as a breast implant is used for breast reconstruction or augmentation, the capsule formed around the implant may tighten, known as capsular contraction. In one attempt to prevent capsular contraction from forming on the surface of an implant, implants have been made with a textured surface. The textured surface breaks up the capsule and helps to prevent contraction. However, texturing the surface of implants has limitations. For example, the textured surface does not work in a number of cases. Further, the implant itself may adhere to the tissue thus limiting the natural movement of the implant.
In an attempt to address the aforementioned problems, a new method for providing a textured surface that is independent of the implant shell has been developed. The implant used is preferably an adjustable or multi-lumen implant with means for increasing and/or decreasing the size of the implant as defined in my co-pending U.S. patent application Ser. No. 12/496,365, filed on Jul. 1, 2009 and based on a Provisional Application filed on Nov. 5, 2008, with the title “Multi-Lumen Breast Prosthesis and Improved Valve Assembly Therefore”.
Notwithstanding the above it is Applicant's belief that there is a need and a potential market for an improved textured surface implant and a method for breast implant reconstruction and augmentation in accordance with the present invention. There should be a need and a market for such implants because they provide better anchoring, shape enhancement and less problems with capsular contraction. Further, it is believed that such implants can be marketed at a competitive price, are durable, improve the rate of healing and lead to more satisfactory results.